BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS LASER

    MDR report key: 842944 · Received April 27, 2007

    Report

    Report Number
    2032002-2007-00047
    Event Type
    Injury
    Date Received
    April 27, 2007
    Date of Event
    March 30, 2007
    Report Date
    March 30, 2007
    Manufacturer
    INTRALASE CORP.
    Product Code
    HQF
    PMA / PMN Number
    k060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 2/06/07, A FIELD SERVICE ENGINEER PERFORMED A SCHEDULED PREVENTATIVE MAINTENANCE. THE LASER SYSTEM MET SPECIFICATIONS AND PERFORMED AS INTENDED. ON 3/15/07, AN INTRALASE CLINICAL APPLICATIONS SPECIALIST (CAS) VISITED THE SITE AND NOTICED THE LASER SETTINGS ARE BEING MODIFIED ON A CONTINUOUS BASIS, AGAINST CAS' ADVICE. THE SITE HAS HAD ON-GOING CONSTRUCTION ADJACENT TO THE SURGICAL SUITE SINCE 2006. AN ENVIRONMENTAL COMPANY EVALUATED THE SURGICAL SITE 1/25/07 AND NOTED THE VENTILATION SYSTEM WAS NOT WORKING EFFECTIVELY, MOST LIKELY DUE TO AN IMPROPERLY INSTALLED AIR FILTER. EVEN THOUGH THE SITE USES POWDER FREE GLOVES, WHITE POWDER WAS OBSERVED ON EQUIPMENT AND NOTED IN THE ENVIRONMENTAL REPORT. ON 3/29/07, AN INTRALASE DIRECTOR OF CLINICAL SUPPORT FOUND THE LASER SYSTEM MET SPECIFICATIONS AND PERFORMED AS INTENDED. IT SHOULD BE NOTED THE AMERICAN ACADEMY OF OPHTHALMOLOGY (AAO) RECOMMENDS TREATING STAGES 1 & 2 DLK WITH TOPICAL STEROIDS AND OBSERVATION. THE AAO DOES NOT RECOMMEND PERFORMING A FLAP LIFT & RINSE AT THESE MILD STAGES. AIR FILTERS HAVEN'T BEEN CHANGED AS RECOMMENDED BY ENVIRONMENTAL COMPANY SINCE 01/25/2007.

    Description of Event or Problem · 1

    THE INTRALASE FS LASER WAS USED TO CREATE BILATERAL CORNEAL FLAPS FOR LASIK SURGERY IN 2007. ONE DAY POSTOPERATIVELY, THE NEXT DAY, THE PT PRESENTED WITH STAGE 1+ DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH (OU) EYES AND A FLAP LIFT AND RINSE WAS PERFORMED. PT WAS TREATED WITH TOPICAL STEROIDS AND A BANDAGE SOFT CONTACT LENS (BSCL) WAS PLACED OU. THE FOLLOWING DAY, THE DR OPTED TO PERFORM A SECOND FLAP LIFT AND RINSE OU, NO BSCL PLACED. THE PT'S PREOPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 BOTH (OU) EYES. POSTOPERATIVE BCVA IS 20/20-1 OD AND 20/30+1 OS. PT IS RESPONDING TO TREATMENT AND DLK HAS RESOLVED. THE ASSOCIATION BETWEEN THE EVENT AND THE DEVICE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRALASE FS LASER LASER KERATOME HQF INTRALASE CORP. 20003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention